(9 days)
Liquichek ANA Control, Centromere Pattern is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing of antinuclear antibodies (ANA).
Liquichek ANA Controllee preservatives and stablizers. This product is prepared from human serum with added preservatives and stabilizers. This product is provided in liquid form for convenience. This product contains 0.1% sodium azide as a provided in liqu
This device, the Bio-Rad Liquichek ANA Control, Centromere Pattern, is a quality control product for laboratory testing, not an AI/ML powered medical device. Therefore, the standard information regarding acceptance criteria and studies proving the device meets them, in the typical sense of AI/ML performance metrics, is not directly applicable.
However, I can extract information related to its intended use, comparative characteristics to a predicate device, and the regulatory process which implies its "acceptance" for market.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a control product, its "performance" is primarily defined by its characteristics and its ability to serve its intended purpose in monitoring indirect immunofluorescent testing. The provided document details a comparison to a predicate device, showing the similarities in key attributes which serve as the basis for its substantial equivalence.
| Characteristic | Predicate Device: Kallestad Quantafluor Autoantibody Positive Control | Bio-Rad Liquichek ANA Control, Centromere Pattern (New Device) |
|---|---|---|
| Intended Use | Autoantibody positive control for Kallestad Quantafluor Fluorescent Autoantibody Test with mouse kidney, mouse stomach/kidney, Hep-2 cell line, or Crithidia luciliae substrates. | An unassayed quality control serum for monitoring indirect immunofluorescent testing of antinuclear antibodies (ANA). |
| Form | Lyophilized | Liquid |
| Matrix | Human Serum | Human Serum |
| Levels | Positive | Negative, Positive, High Positive |
| Storage | 2-8°C | 2-8°C |
| Analytes | ANA (Centromere, SSA, SSB, Scl-70, Sm, RNP, Spindle, Nucleolar), AMA, ASMA, APCA, Anti-nDNA | ANA (Centromere Pattern) |
| Open Vial Claim | 6 weeks at 2-8°C, 4 months at -20°C | 30 Days at 2-8°C |
"Acceptance Criteria" for this type of device would generally revolve around:
- Manufacturing Quality: Ensuring the product is manufactured consistently and meets defined specifications (e.g., concentration of ANA, stability, sterility).
- Stability: Maintaining its stated characteristics over its shelf life and open-vial period.
- Suitability for Intended Use: Demonstrating that it correctly functions as a control in ANA indirect immunofluorescent assays.
- Substantial Equivalence: Proving to the FDA that it is as safe and effective as a legally marketed predicate device.
The provided document details the basis for its substantial equivalence to the Kallestad Quantafluor Autoantibody Positive Control, highlighting shared matrix (human serum) and storage conditions, and a similar intended use as a control for ANA testing (though the new device is specific to Centromere Pattern). The differences (liquid form, specific ANA pattern, multiple levels, different open vial claim) would have been assessed by the FDA to ensure they don't raise new questions of safety or effectiveness.
2. Sample Size for the Test Set and Data Provenance:
This information is not applicable in the context of this 510(k) submission. The device is a quality control material, not a diagnostic test with a "test set" of patient data in the AI/ML sense. The "testing" for such a device would typically involve internal validation by the manufacturer to demonstrate its stability and manufacturing consistency, and then its performance as a control within specific lab assays. No details on such internal testing are provided in this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable. There is no "ground truth" establishment in the context of patient data for this quality control product. Its "truth" is its inherent composition and stability as a control material.
4. Adjudication Method:
This information is not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not applicable. This is not an AI-powered diagnostic device, and therefore, no MRMC studies comparing human readers with and without AI assistance would be performed.
6. Standalone Performance:
This information is not applicable in the AI/ML sense. "Standalone performance" for this device would refer to its intrinsic characteristics (e.g., concentration of antibodies, stability) which are verified during manufacturing and quality control. The 510(k) primarily focuses on demonstrating substantial equivalence, not a standalone performance study report.
7. Type of Ground Truth Used:
For a quality control material, the "ground truth" is intrinsically defined by its manufacturing specifications and the characterization of the human serum used. The manufacturer would establish the expected range for the Centromere ANA pattern in their control lots. This isn't pathology, outcomes data, or expert consensus in the same way it would be for a clinical diagnostic test for patient samples. Instead, it's about the composition and stability of the control product itself.
8. Sample Size for the Training Set:
This information is not applicable as this is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable.
Summary of Regulatory Acceptance for K984397:
The FDA determined that the Bio-Rad Liquichek ANA Control, Centromere Pattern, was substantially equivalent to the predicate device (Kallestad Quantafluor Autoantibody Positive Control). This determination indicates that the FDA reviewed the information provided by Bio-Rad (including the comparison table above) and concluded that the new device is as safe and effective as the legally marketed predicate device for its stated intended use. This regulatory decision serves as the "acceptance" that the device meets the necessary criteria for market entry.
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Bio-Rad Laboratories
e, California 92618-2017 ephone: (949) 598-1200
510(k) Summary
Submitter Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA (949)598-1285 Fax (949)598-1555
Contact Person Elizabeth Platt
Date of Summary Preparation December 8, 1998
Device (Trade & Common Name) Liquichek ANA Control, Centromere Pattern
Classification Name Class II. 82DHN CFR 866.5100: Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control.
Devices to Which Substantial Equivalence is Claimed Kallestad Quantafluor Autoantibody Positive Control Sanofi Diagnostics Pasteur Chaska, Minnesota K813592
Statement of Intended Use
Liquichek ANA Control, Centromere Pattern is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing of antinuclear antibodies (ANA).
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Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad Laboratories. The logo is in white text on a black background. The text is bold and sans-serif. The logo is enclosed in a rounded rectangle.
Bio-Rad Laboratories
Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
Description of the Device
Liquichek ANA Controllee
preservatives and stablizers. This product is prepared from human serum with added preservatives and stabilizers. This product is provided in liquid form for convenience. This product contains 0.1% sodium azide as a provided in liqu
Statement of How Technological Characteristics Compare to Substantial Equivalent
Device Device
A table is provided below comparing the similarities between the Bio-Rad Liquichek ANA Control, Centroller of Similanties belween the Bio-Rad Liquichek
claimed claimed.
| Kallestad Quantafluor Autoantibody PositiveControl | Bio-Rad LiquichekANA Control, Centromere Pattern | |
|---|---|---|
| Intended Use | Autoantibody positive control for Kallestad Quantafluor Fluorescent Autoantobody Test with mouse kidney, mouse stomach/kidney, Hep-2 cell line, or Crithidia luciliae substrates. | An unassayed quality control serum for monitoring indirect immunofluorescent testing of antinuclear antibodies (ANA). |
| Form | Lyophilized | Liquid |
| Matrix | Human Serum | Human Serum |
| Levels | Positive | Negative, Positive, High Positive |
| Storage | 2-8°C | 2-8°C |
| Analytes | ANA (Centromere, SSA, SSB, Scl-70, Sm, RNP, Spindle, Nucleolar)AMAASMAAPCAAnti-nDNA | ANA (Centromere Pattern) |
| Open Vial Claim | 6 weeks at 2-8°C4 months at -20°C | 30 Days at 2-8°C |
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight. The symbol is composed of three curved lines that form the wings and body of the bird.
DEC 18 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Elizabeth Platt Regulatory Affairs Supervisor Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA 92618
Re: K984397 Trade Name: Liquichek ANA Control, Centromere Pattern, Model 203 Regulatory Class: II Product Code: DHN Dated: December 8, 1998 Received: December 9, 1998
Dear Ms. Platt:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number: _______________________________________________________________________________________________________________________________________________________________ Device Name: Liquichek ANA Control, Centromere Pattern
Indications for Use:
Liquichek ANA Control, Centromere Pattern is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing of antinuclear antibodies (ANA).
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Concurrence of CDRH, Office of Device Evaluation)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | 4984397 |
| Prescription Use | / | OR Over-The Counter Use |
|---|---|---|
| ------------------ | -------------- | ------------------------- |
§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).